Rapid Antidepressant Response to Ketamine and Impact on Healthcare Utilization After Administration in the Emergency Department
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Depression Symptom Response
研究概览
简要总结
The purpose of this study is to examine the effect of a low-dose ketamine infusion on depression symptoms within the Emergency Department (ED) visit, and healthcare utilization after leaving the ED, when administered in the ED for depression or suicidal ideation.
详细描述
Patients will be identified based on either a chief complaint of suicidal ideation, suicide attempt, or severe depression, or if the patient indicates during intake assessment that they have thoughts of harming or killing their self. Identified patients will be assessed by the ED provider for inclusion and exclusion criteria. If the patient is a candidate for the trial and gives their informed consent for enrollment, they will be randomized to receive either ketamine or placebo by a computer program that maintains blinding. The patient will be assessed by psychiatry for disposition and treatment plan prior to receiving the study drug, and will be reassessed four hours after the infusion. Thirty days after the patient leaves the hospital (either leaves from the ED or is discharged from inpatient admission), they will be contacted to follow up on their healthcare utilization after discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 18 years of age and older
- •Presenting to the ED with a chief complaint of severe depression or suicidality, or presenting to the ED with any other chief complaint but answering "yes" to "Thoughts of harming/killing yourself?" during intake/triage
排除标准
- •Acute mania or psychosis
- •Enrollment in trial during a prior emergency department visit
- •History of ketamine abuse or dependence
- •Known hypersensitivity to ketamine
- •Acute intoxication with any drug of abuse (including alcohol)
- •Pregnancy or lactation
- •Any condition that would place the patient at serious risk of harm from an increase in blood pressure (e.g. history of intracerebral hemorrhage, aneurysmal vascular disease, or arteriovenous malformation)
- •Assessing provider does not want to enroll patient for any other reason, based on their clinical judgement
研究组 & 干预措施
Ketamine
Ketamine 0.5 mg/kg in 0.9% sodium chloride, total volume 50 mL via intravenous infusion over 40 minutes for one dose.
干预措施: Ketamine (Drug)
Placebo
0.9% sodium chloride, total volume 50 mL via intravenous infusion over 40 minutes for one dose
干预措施: Sodium Chloride 0.9% (Drug)
结局指标
主要结局
Depression Symptom Response
时间窗: Baseline, 4 hours
Patients will be classified as a responder or non-responder, with a response defined as a decrease by 50% or greater for the combined depressive symptom scores of the Brief Psychiatric Rating Scale (BPRS), which includes the following domains: emotional withdrawal, guilt feelings, depressed mood, blunted affect, feelings of inferiority, and suicidal ideation. The total depressive symptom score ranges from 6-42, with a higher score indicating a higher level of severity. Response rate will be compared between the treatment and placebo groups.
ED Return Visit
时间窗: 30 days from discharge
Number of return visits to the emergency department for any psychiatric reason
次要结局
- Intoxication(Baseline, 2 hours, 4 hours)
- Outpatient follow-up(30 days from discharge)
- Changes in Individual Psychiatric Symptoms(Baseline, 4 hours)
- Length of stay(Time from arrival in ED to discharge, either directly from the ED or after inpatient admission. Average length of stay is less than 14 days.)
研究者
Kathryn Bress, PharmD
Pharmacist
MercyOne Des Moines Medical Center